MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-27 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER A11812 manufactured by Beckman Coulter, Inc..
[1811872]
A customer contacted beckman coulter inc. (bci) in regards to erroneously low total bilirubin (tbil) results generated by unicel dxc 800 pro synchron chemistry analyzer for two patients. The results were not reported out of the laboratory. Subsequent testing on an alternate analyzer produced higher results. There was no effect to the patients or user.
Patient Sequence No: 1, Text Type: D, B5
[8898318]
The sample was analyzed from the primary tube. Qc was trending downwards. No other system errors were noted and the customer confirmed no other chemistries were affected. On (b)(4) 2010, a bci field service engineer (fse) replaced the reagent and sample syringes. The fse found 3 broken cuvettes, glass in one wash/vacuum probe, and vacuum leak at wash manifold. The fse replaced the whole wash manifold assembly, and performed alignments. The fse calibrated both tbil and dbil (direct bilirubin) and performed 20 rep precision tests on both chemistries. All results were within the specifications. The root cause for this event was hardware. This report is linked to medwatch reports #2050012-2010-01419 and 2050012-2010-01422.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01421 |
| MDR Report Key | 1908445 |
| Report Source | 05 |
| Date Received | 2010-11-27 |
| Date of Report | 2010-10-29 |
| Date of Event | 2010-10-28 |
| Date Mfgr Received | 2010-10-29 |
| Device Manufacturer Date | 2007-12-07 |
| Date Added to Maude | 2012-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMSTRY ANALYZER |
| Product Code | JFM |
| Date Received | 2010-11-27 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-27 |